Pregnancy Induced HypertensionPhase 1NCT02213094
Phase I Study of Nicotinamide for Early Onset Preeclampsia
A Phase 1 study testing Nicotinamide 500 mg and Nicotinamide 1000 mg in people with Pregnancy Induced Hypertension and Superimposed Preeclampsia, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This is a Phase I study of vitamin B3-amide (nicotinamide) dietary supplementation in pregnant women with early onset preeclampsia. The investigators will enroll 10 pregnant women at 24-32 weeks' gestation with the diagnosis of preeclampsia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy Induced Hypertension, Superimposed Preeclampsia, Hypertension
- What is being tested?
- Nicotinamide 500 mg and Nicotinamide 1000 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2014to 3 Dec 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Maternal age 18-45 years
- Informed written consent
- Preeclampsia or new onset hypertension between 24-32 completed weeks' gestation
- Hypertensive complications of pregnancy defined as new onset systolic BP > 140 mm Hg and/or diastolic BP > 90 mm Hg on two occasions 6 hours apart; OR > 300 mg proteinuria on 24 hour urine collection OR urine P/C ratio >0.3;
- Dating criteria based on menstrual dating confirmed by first or second trimester ultrasound OR second trimester ultrasound if menstrual dating unavailable;
- Deemed clinically stable by primary clinician and candidate for expectant management (delayed delivery);
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- Maternal liver function tests < 3x ULN
- Maternal platelet count > 100,000 mm3
- Fetal well-being established by estimated fetal weight > 5th %tile; normal amniotic fluid volume (MVP > 2 cm); normal Umbilical Artery Dopplers; AND reactive NST(non-stress test) or BPP (biophysical profile) > 6
- Plan for expectant management until delivery
- Delivery not anticipated within first 48 hours
Who cannot join
- Preeclampsia < 24 or > 33 weeks' gestation;
- Suspected fetal structural or chromosomal abnormality;
- Pre-existing renal disease (creatinine > 1.5 mg/dL)
- Pre-existing vascular disease (systemic lupus; cardiac disease;)
- Plan for delivery within 48 hours
- Any pre-existing medical condition that would increase risk for liver toxicity (e.g. hepatitis B or C; HIV)
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- Evidence of cerebral dysfunction (seizures; cerebral edema on CT/MRI; headache unresolved with oral analgesics)
- Pulmonary edema
- HELLP (hemolysis, elevated liver enzymes, low platelets syndrome)
- Evidence of liver dysfunction (LFTs > 3x ULN)
- Thrombocytopenia (platelets < 100,000 mm3)
- Evidence of fetal compromise: EFW(estimated fetal weight) < 5th percentile; BPP < 6; absent or reverse diastolic UA blood flow; oligohydramnios (MVP < 2 cm)
- Placental abruption defined as unexplained vaginal bleeding
- Preterm labor defined as regular contractions and cervical change
- Any condition deemed by the investigator to be a risk to mother or fetus in completion of the study
- Any condition deemed by the investigator to require delivery within 48 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Women's Hospital
Chapel Hill, North Carolina, 27599-7516
About this study
This is a Phase I study of vitamin B3-amide (nicotinamide) dietary supplementation in pregnant women with early onset preeclampsia. The investigators will enroll 10 pregnant women at 24-32 weeks' gestation with the diagnosis of preeclampsia. If the woman is anticipated to remain undelivered for 48 hours after diagnosis she will receive vitamin B3-amide, 500 mg/day given in the morning (n=5) or 1000 mg given in the morning (n=5), continuing until delivery or for 14 days, whichever occurs first. Maternal blood will be collected at baseline and twice a day on days 1, 3, and 7 of nicotinamide administration to measure nicotinamide metabolites, The objectives of this Phase I study are to to test safety of nicotinamide.
- Being tested
- Nicotinamide 500 mg, Nicotinamide 1000 mg
- Keywords
- preeclampsia, pregnancy-induced hypertension, nicotinamide
- Medical subject headings
- Hypertension, Pregnancy-Induced, Hypertension, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide 500 mgDrug
Also called Vitamin B3 amide
Nicotinamide 500 mg taken by mouth each morning
Nicotinamide 1000 mgDrug
Also called Vitamin B3 amide
Nicotinamide 1000 mg taken by mouth each morning
| Study group | Role | What they receive |
|---|---|---|
| Nicotinamide 500 mg | Experimental | Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first. Receives: Drug: Nicotinamide 500 mg |
| Nicotinamide 1000 mg | Experimental | Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first. Receives: Drug: Nicotinamide 1000 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Specific adverse events were Maternal liver toxicity, defined as > 3x ULN of ALT(Alanine amniotransferase) or AST (Aspartate amniotransferase), maternal report of side effects, and fetal adverse effects.
Measured: Within 48 hours of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study start1 Jan 2014
- Primary completion3 Dec 2015
- Study completion3 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pregnancy Induced HypertensionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Phase 1 dose escalation study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Kim A Boggess, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213094
- Sponsor's protocol ID
- 13-2203
- Status last verified
- Mar 2018
- First submitted
- 7 Aug 2014
- Last updated
- 2 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Nicotinamide for Early Onset Preeclampsia
- ClinicalTrials.gov ID
- NCT02213094
- Acronym / sponsor ID
- 13-2203
- Keywords
- preeclampsia, pregnancy-induced hypertension, nicotinamide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 3 Dec 2015 (actual)
- Study completion
- 3 Dec 2015 (actual)
- First posted
- 11 Aug 2014 (estimated)
- Results
- Posted 2 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I study of vitamin B3-amide (nicotinamide) dietary supplementation in pregnant women with early onset preeclampsia. The investigators will enroll 10 pregnant women at 24-32 weeks' gestation with the diagnosis of preeclampsia. If the woman is anticipated to remain undelivered for 48 hours after diagnosis she will receive vitamin B3-amide, 500 mg/day given in the morning (n=5) or 1000 mg given in the morning (n=5), continuing until delivery or for 14 days, whichever occurs first. Maternal blood will be collected at baseline and twice a day on days 1, 3, and 7 of nicotinamide administration to measure nicotinamide metabolites, The objectives of this Phase I study are to to test safety of nicotinamide.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1 dose escalation study
| Arm | Type | Receives |
|---|---|---|
| Nicotinamide 500 mg | Experimental | Drug: Nicotinamide 500 mgNicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first. |
| Nicotinamide 1000 mg | Experimental | Drug: Nicotinamide 1000 mgNicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Maternal age 18-45 years
- Informed written consent
- Preeclampsia or new onset hypertension between 24-32 completed weeks' gestation
- Maternal liver function tests < 3x ULN
- Maternal platelet count > 100,000 mm3
Key exclusion criteria (16 listed)
- Preeclampsia < 24 or > 33 weeks' gestation;
- Suspected fetal structural or chromosomal abnormality;
- Pre-existing renal disease (creatinine > 1.5 mg/dL)
- Pre-existing vascular disease (systemic lupus; cardiac disease;)
- Plan for delivery within 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotinamide 500 mgAlso: Vitamin B3 amideNicotinamide 500 mg taken by mouth each morning | Drug | Nicotinamide 500 mg |
| Nicotinamide 1000 mgAlso: Vitamin B3 amideNicotinamide 1000 mg taken by mouth each morning | Drug | Nicotinamide 1000 mg |
Primary outcome
Number of Participants With Adverse Events
Time frame: Within 48 hours of dosing
Specific adverse events were Maternal liver toxicity, defined as > 3x ULN of ALT(Alanine amniotransferase) or AST (Aspartate amniotransferase), maternal report of side effects, and fetal adverse effects.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim A Boggess, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nicotinamide 500 mg and Nicotinamide 1000 mg in people with Pregnancy Induced Hypertension and Superimposed Preeclampsia, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: Within 48 hours of dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2018; AzTrials last refreshed its copy on 7 Nov 2026.